Helicobacter Pylori Infection Clinical Trial
Official title:
Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
Verified date | November 2023 |
Source | National Cancer Center, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.
Status | Active, not recruiting |
Enrollment | 470 |
Est. completion date | June 2030 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Early Gastric cancer or high grade dysplasia confirmed by endoscopy - Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia - Submucosal invasion is not suspected - No evidence of ulceration or ulcer scar within the lesion - Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test - Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system - Informed consent should be signed Exclusion Criteria: - Recurrent gastric cancer - Previous serious side effect to antibiotics - H. pylori eradication treatment history - Poorly differentiated adenocarcinoma or Signet ring cell carcinoma - Undergoing operation due to complication of EMR - Undergoing operation due to remnant cancer - Other malignancy within the past 5 years - Pregnant or nursing women - Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases - Psychiatric disorder that would preclude compliance |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center, Korea | Goyang | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement (histological) of glandular atrophy | Improvement of glandular atrophy at the corpus lesser curvature | 3 years after enrollment | |
Primary | Incidence of metachronous gastric cancer | Comparison of metachronous gastric cancer according to the allocated treatment | 3 years after last patient enrollment | |
Secondary | Incidence of new gastric dysplasia | Comparison of new gastric dysplasia according to the allocated treatment | 3 years after last patient enrollment | |
Secondary | Overall survival | Comparison of overall survival according to the allocated treatment | 3 years after last patient enrollment |
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